The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)

November 20, 2013 updated by: National Taiwan University Hospital
The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients

Study Overview

Status

Completed

Conditions

Detailed Description

The analysis of Heart Rate Variability with 24hrs Holter ECG and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25)

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult age>18 years old

Description

Inclusion Criteria:

  • critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25)

Exclusion Criteria:

  • pacemaker rhythm, not sign the permit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
ECMO Patients survived
Control
ECMO Patient died

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients
Time Frame: 2-4weeks

  1. Outcome measurement:

    The measure is a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group), no changes are required

  2. List the primary condition or disease being studied Shock needing ECMO support
2-4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200804046R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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